MEDDEV 2.7/1 rev.4 published - June 2016

Elsmar Forum Sponsor

Yasuaki

Starting to get Involved
#32
I think each Notified Body is learning how to address MEDDEV 2.7.1 rev.4 for several years from its competent authority.
So, I think the more later the stricker.
 

Roland chung

Trusted Information Resource
#34
Hi all,

Could anyone tell me what is the meaning of "use similar deployment methods (if relevant)" which appears in the A1 (Demonstration of equivalence)?

Thanks,
Roland
 

Marcelo

Inactive Registered Visitor
#35
Usually, method of deployment is a term used with devices that needs to be inserted in the body such as catheters, stents, etc., related to how they are put into their necessary positions to work. But I've never seen a clear definition of that anywhere.
 

kreid

Involved In Discussions
#37
Has anyone had discussions with their notified body on the appendix - 'A11. Information on declarations of interests' and how they will oversee this aspect?

From the text it seems to imply to me that Evaluators should be independent of the company carrying out the CER and of the device.

Also do you think the MEDDEV includes the Author of the CER as an evaluator?

Thanks, in advance.
 

FoGia

Involved In Discussions
#38
I haven't interacted with a NB regarding the declaration of interest but here are some thoughts:
- The MEDDEV doesn't require the clinical evaluators to be independent from the company, but obviously you would want to include independent evaluators to ensure the objectivity of the report
- There is no definition of 'author' in the MEDDEV either, the clinical evaluators are the authors of the document, and they can consist out of a team with the skills identified in the guidance
The Me
 
G
#39
For the CER template, we are just putting the suggested fields into our work instruction. We had teams get a non-conformance for not using the correct "version" of the template.

Report Format
A suggested report format can be found below.
The contents of the report will vary based on the nature and history of the device under evaluation. If the format does not fit the needs of your device, it is acceptable to create a solution-specific format.
Refer to Appendix A9 of MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies June 2016 for further information regarding the content of each section.
1. Summary
2. Scope
Device description
Intended use
Definition of claims
Regulatory status
History of changes
3. Background
Justification for search strategy
Standards and guidance
Users and use patterns
Therapeutic alternatives
Known hazards
4. Device under evaluation
Methodology
Equivalence (only when equivalence is claimed)
Manufacturer data
Literature data
Analysis
ER #1: Safety and Risk/Benefit
ER #3: Performance
ER #6: Side effects
5. Conclusions
ER compliance status
Risk/benefit profile
Acceptability
Residual risks
6. Administrative
Update
Dates and signatures
Thanks TB. May I ask your approximate word count for each section (a guess is fine). I think this will help a lot of people. Thanks G
 
#40
Has anyone had discussions with their notified body on the appendix - 'A11. Information on declarations of interests' and how they will oversee this aspect?

From the text it seems to imply to me that Evaluators should be independent of the company carrying out the CER and of the device.

Also do you think the MEDDEV includes the Author of the CER as an evaluator?

Thanks, in advance.
We have used the bullet points of A.11 to create a simple table for each evaluator (and family). It is a pure 'cut and copy' job.
In our case the evaluator of record is a long standing employee of the company. The full relationship has been clearly disclosed.
He did not actually author the report but does have a relevant higher degree.
The actual author was a contract research organisation.
So far this approach has been accepted by our NB.
 
Thread starter Similar threads Forum Replies Date
F MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation EU Medical Device Regulations 4
E Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR? EU Medical Device Regulations 4
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
dgrainger Informational Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 EU Medical Device Regulations 1
M CEP requirements in MEDDEV 2.7/1, rev 4 and MDR - Are all MEDDEV requirements still applicable? EU Medical Device Regulations 7
K MEDDEV 2.4/1 rev. 9 Classification EU Medical Device Regulations 1
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
J CER - Literature search strategy and PMV data Timeline - MEDDEV 2.7.1/ Rev 4 CE Marking (Conformité Européene) / CB Scheme 2
S Gap Analysis MDR req/MEDDEV 2.7.1 rev 4 EU Medical Device Regulations 3
H CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4 CE Marking (Conformité Européene) / CB Scheme 9
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
Q Sample of the MEDDEV 2.7.1 rev 4 Clinical Evaluation Report wanted Document Control Systems, Procedures, Forms and Templates 18
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
R Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template ISO 13485:2016 - Medical Device Quality Management Systems 6
K MEDDEV 2.7/1 Rev 4 Appendix - A11 - Declarations of Interests EU Medical Device Regulations 2
F MEDDEV 2.7/1 rev 4 - Clinical Performance & Clinical Safety Claims EU Medical Device Regulations 3
E Gap Analysis between MEDDEV 2.7/1 rev.4 vs. rev.3 wanted EU Medical Device Regulations 3
S Revised MEDDEV 2.12-1 rev 8 Vigilance System - Released EU Medical Device Regulations 3
M MEDDEV 2.12.1 rev 6 Trending of Non-Reportable Events question ISO 13485:2016 - Medical Device Quality Management Systems 4
bio_subbu European Medical Devices Classification ?MEDDEV 2. 4/1 Rev. 9 June 2010? ISO 13485:2016 - Medical Device Quality Management Systems 5
T Vigilance System MEDDEV 2009 changes - MEDDEV 2.12-1 rev 6 for Vigilance System EU Medical Device Regulations 1
bio_subbu Clinical Evaluation - MEDDEV 2.7.1 Rev. 3 Released - December 2009 EU Medical Device Regulations 0
A Contradictions in the reporting timelines of IVD Directive and MEDDEV 2.12-1 Rev 5 ISO 13485:2016 - Medical Device Quality Management Systems 2
J EU Vigilance (updated MEDDEV rev.5) - Internal Forms EU Medical Device Regulations 13
Z MEDDEV 2.12-1 Rev 5 Reportability Decision Tree? Vigilance Reporting Procedure EU Medical Device Regulations 18
G MEDDEV 2.12-1 rev. 5 released ISO 13485:2016 - Medical Device Quality Management Systems 0
T The “use-by“ time limit - Terminology discrepancy - MEDDEV & HS EU Medical Device Regulations 0
K Measuring Function MEDDEV 2.1/5 relation with MDD 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 1
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
J MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex) EU Medical Device Regulations 1
Ronen E Informational The future of MEDDEV 2.7/1 EU Medical Device Regulations 4
R Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template EU Medical Device Regulations 4
M Clinical Evaluation - MEDDEV 2.7/1 rev4 - Literature route Other Medical Device Related Standards 2
T MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41 Other Medical Device Related Standards 3
P Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5/5 ISO 13485:2016 - Medical Device Quality Management Systems 4
Sam Lazzara Clinical Evaluation MEDDEV Guidelines SmackDown - 2017 EU Medical Device Regulations 3
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
R Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding EU Medical Device Regulations 16
J Where to get meddev FSCA (Field Safety Corrective Actions) trainings EU Medical Device Regulations 7
Y Transition Period for MEDDEV 2.7.1 EU Medical Device Regulations 8
C MEDDEV equivalent requirement to CFR 806.20 EU Medical Device Regulations 2
J Good training or seminars to attend for MEDDEV 2.12-1 recommendations wanted EU Medical Device Regulations 3
S NB-MED, NBOG, IMDRF and MEDDEV hierarchy EU Medical Device Regulations 3
M Australian Meddev Regulations Updated 5 Nov 2014 Other Medical Device Regulations World-Wide 0
B Inquiry about MEDDEV 2.12/2 rev2 - PMCF studies EU Medical Device Regulations 3
D Vigilance Trend reporting requirements of Meddev 2.12/ver 7 in the EU Document Control Systems, Procedures, Forms and Templates 1
N MEDDEV guideline on Post Market Surveillance (PMS) EU Medical Device Regulations 8
bio_subbu EU publishes revised guidance on Medical Devices Vigilance system MEDDEV 2.12-1 Rev7 EU Medical Device Regulations 8
bio_subbu EU publishes several new & Revised MEDDEV guidance documents (FEB 2012) EU Medical Device Regulations 0

Similar threads

Top Bottom